The Study of Soy Isoflavones in Asthma
SOYA
3 other identifiers
interventional
386
1 country
18
Brief Summary
The trial is designed to study the effects of soy supplements on asthma control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Mar 2010
Typical duration for phase_4 asthma
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2009
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
January 14, 2016
CompletedJanuary 14, 2016
December 1, 2015
2.4 years
December 4, 2009
December 10, 2015
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline to 24 Weeks for FEV1
24 weeks
Study Arms (2)
Soy Isoflavone
ACTIVE COMPARATOROral isoflavone supplement (100 mg/day)
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Oral soy isoflavone supplement (100 mg/day)
Eligibility Criteria
You may qualify if:
- Age 12 or older
- Physician diagnosed asthma
- FEV1 equal or greater than 50% predicted pre-bronchodilator
- At least 12% increase in FEV1 15-3 minutes after inhaling 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 8 mg/mL). Either of these can be available from the previous 2 years
- Currently prescribed daily controller asthma medication
- Poor asthma control (at least one of the following)
- A score of 1.5 or greater on the Juniper Asthma Control Questionnaire
- Use of beta-agonist for asthma symptoms two or more times per week
- Nocturnal awakening with asthma symptoms more than once per week
- Two or more episodes of asthma symptoms in the past 12 months with each requiring at least one of the following: emergency department visit, unscheduled physician visit, prednisone course, hospitalization
- Smoking status
- Non-smoker for 6 months or longer
- Less than 10 pack-years smoking history
You may not qualify if:
- Pulmonary function
- FEV1 less than 50% predicted pre-bronchodilator
- Other major chronic illnesses
- Conditions which in the judgment of the study physician would interfere with participation in the study, e.g., non-skin cancer, endocrine disease, coronary artery disease, severe hypertension, immunodeficiency states
- History of thyroid disease, breast cancer, ovarian, or endometrial cancer
- History of physician diagnosis of chronic bronchitis, emphysema, or COPD
- Medication use
- Current consumption of soy isoflavone supplements
- Oral corticosteroid use within the past 6 weeks
- Use of tamoxifen
- Use of an investigational treatment in the previous 30 days
- "Drug" allergy
- Known adverse reaction to genistein, other phytoestrogens, or soy products
- Females of childbearing potential
- Pregnant or lactating. Participants must agree to use effective contraception during the trial.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of Arizona
Tucson, Arizona, 85724, United States
University of California, San Diego
San Diego, California, 92103, United States
National Jewish Health
Denver, Colorado, 80206, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
University of South Florida College of Medicine
Tampa, Florida, 33613, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60612, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
North Shore - Long Island Jewish Health System
New Hyde Park, New York, 11040, United States
New York University School of Medicine
New York, New York, 10016, United States
New York Medical College
Valhalla, New York, 10595, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Davis Heart and Lung Research Institute
Columbus, Ohio, 43210, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Vermont Lung Center at the University of Vermont
Burlington, Vermont, 05405, United States
Related Publications (2)
Smith LJ, Kalhan R, Wise RA, Sugar EA, Lima JJ, Irvin CG, Dozor AJ, Holbrook JT; American Lung Association Asthma Clinical Research Centers. Effect of a soy isoflavone supplement on lung function and clinical outcomes in patients with poorly controlled asthma: a randomized clinical trial. JAMA. 2015 May 26;313(20):2033-43. doi: 10.1001/jama.2015.5024.
PMID: 26010632RESULTKaminsky DA, He J, Henderson R, Dixon AE, Irvin CG, Mastronarde J, Smith LJ, Sugar EA, Wise RA, Holbrook JT. Bronchodilator response does not associate with asthma control or symptom burden among patients with poorly controlled asthma. Respir Med. 2023 Nov;218:107375. doi: 10.1016/j.rmed.2023.107375. Epub 2023 Aug 1.
PMID: 37536444DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert A. Wise
- Organization
- ALA - ACRC
Study Officials
- PRINCIPAL INVESTIGATOR
Lewis J Smith, MD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Data Coordinating Center
Study Record Dates
First Submitted
December 4, 2009
First Posted
January 20, 2010
Study Start
March 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
January 14, 2016
Results First Posted
January 14, 2016
Record last verified: 2015-12